Senior Director Global Regulatory Affairs Strategy

5 hours ago


Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

Global Regulatory Affairs Strategy Lead

Daiichi Sankyo Group is dedicated to creating and supplying innovative pharmaceutical therapies to improve standards of care and address diverse, unmet medical needs globally. As a key member of our team, you will be responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other regions.

This position ensures alignment of regulatory strategies within the department and adherence to therapeutic area direction and corporate objectives. You will lead a multidisciplinary Global Regulatory Team (GRT) to develop global regulatory strategy and plans for assigned global projects.

Key responsibilities include:

  • Gain endorsement from the Global Project Team (GPT) for these plans, ensuring appropriateness throughout the product's lifecycle and across different indications.
  • Represent Global Regulatory Affairs on the GPT, Daiichi Sankyo governance processes, and on Joint Alliances.
  • Assess and articulate regional interdependencies, program regulatory risks, and opportunities in the development of global regulatory strategy and plans.

Requirements include a Bachelor's Degree in a scientific discipline and 10 or more years of experience in the pharmaceutical industry, with 7 or more years of direct regulatory affairs experience, including experience in regulatory submissions in Oncology.

What We Offer

Daiichi Sankyo, Inc. is an equal opportunity employer and welcomes applications from diverse candidates. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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